Prostate Cancer Clinical Trial

A Study of Two Dose Levels of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer

Summary

Study CP-MGC018-03 is a randomized, open-label, seamless, Phase 2/3 study. The study will enroll participants with metastatic castration-resistant prostate cancer (mCRPC) previously treated with one prior androgen receptor axis-targeted therapy (ARAT) and one prior taxane-containing regimen. ARAT includes abiraterone, enzalutamide, or apalutamide. Participants may have received up to 1 prior cabazitaxel regimen, but no other chemotherapy agents.

The Phase 2 stage will assess efficacy and tolerability of two vobramitamab duocarmazine (MGC018) experimental arms (2.0 mg/kg Q4W and 2.7 mg/kg Q4W) compared to the control arm (abiraterone or enzalutamide). Approximately 150 participants will be randomized 1:1:1 in Phase 2 among the three study treatment arms (two vobramitamab duocarmazine experimental arms and one control arm). An interim analysis will be performed to select the Phase 3 dose regimen for the vobramitamab duocarmazine experimental arm for Phase 3 after approximately 150 participants enrolled in Phase 2 have been followed for at least 2 months (60 days).

The Phase 3 stage will assess efficacy of the selected dose regimen for the vobramitamab duocarmazine experimental arm versus the control arm (abiraterone or enzalutamide). Approximately 270 additional participants will be randomized 1:1 between each study treatment arm in Phase 3 (one vobramitamab duocarmazine experimental arm and the control arm).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the prostate without evidence of neuroendocrine differentiation, signet cell, or small cell features.
Participants must have ≥ 1 metastatic lesion that is present on magnetic resonance imaging (MRI), computed tomography (CT), or bone scan obtained ≤ 28 days prior to initiation of study treatment.
Tumor progression at study entry documented by PSA or imaging per PCWG3 criteria
Received 1 prior ARAT for metastatic or non-metastatic, castration-sensitive or castration-resistant prostate cancer. A second ARAT regimen of <60 days used as bridging to lutetium-177 is permitted.
Availability of archival or formalin-fixed paraffin-embedded (FFPE) tumor tissue sample for participants with metastasis to internal organs
Acceptable physical condition and laboratory values.

Exclusion Criteria:

Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
Received >1 prior taxane-containing regimen for prostate cancer. A second taxane regimen of <60 days used as bridging for lutetium-177 is permitted.
Received >3 total prior therapies for mCRPC
Participants with known BRCA or ATM mutation (germline or somatic) are not eligible unless they received prior treatment with a PARP inhibitor where available, indicated and tolerated.
Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 2 years from first dose of study treatment. Participants who had curative therapy for non-melanomatous skin cancer or for localized malignancy are eligible.
Untreated, symptomatic central nervous system (CNS) metastasis.
Prior treatment with any B7-H3 targeted agent for cancer,
Contradictions to the use of corticosteroid treatment
Prior stem cell, tissue, or solid organ transplant.
Use of products that have published anti-prostate cancer activity or are known to decrease PSA.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05551117

Recruitment Status:

Recruiting

Sponsor:

MacroGenics

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There are 29 Locations for this study

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Compassionate Cancer Care Medical Group
Fountain Valley California, 92708, United States More Info
Shama Hussain
Contact
Eric Lee, MD
Principal Investigator
University of California Los Angeles (UCLA) Community Cancer Care
Los Angeles California, 90095, United States More Info
Sandy Hernandez
Contact
John Shen, MD
Principal Investigator
The University of Florida Health System - UF Health Urology - Jacksonville
Jacksonville Florida, 32209, United States More Info
Guerline St Louis
Contact
Kethanda Balaji, MD
Principal Investigator
Mid Florida Hematology and Oncology Center
Orange City Florida, 32763, United States More Info
Kiran Penta
Contact
Santosh Nair, MD
Principal Investigator
Pontchartrain Cancer Center
Covington Louisiana, 70433, United States More Info
Courtney Tergre
Contact
David Oubre, MD
Principal Investigator
Gabrail Cancer Center
Canton Ohio, 44718, United States More Info
Kimberly Roby
Contact
Nashat Gabrail, MD
Principal Investigator
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Katie Valipour
Contact
Neal Shore, MD
Principal Investigator
University of Virginia Comprehensive Cancer Center
Charlottesville Virginia, 22908, United States More Info
Jemima Tennant
Contact
Robert Driecer, MD
Principal Investigator
Virginia Cancer Specalists
Fairfax Virginia, 22031, United States More Info
Janice Alcaide
Contact
Alexander Spira
Principal Investigator
Fred Hutchinson Cancer Center
Seattle Washington, 98109, United States More Info
Jane Romani
Contact
Jessica Hawley, MD
Principal Investigator
Cabrini Health- Malvern
Malvern Victoria, 3144, Australia More Info
Koby Scarff
Contact
David Pook
Principal Investigator
Peter MacCallum Cancer Centre
Melbourne Victoria, 3000, Australia More Info
Jesse Burke
Contact
Shahneen Sandhu, MD
Principal Investigator
(Grand Hopital de Charleroi) GHDC
Charleroi Hainaut, 6000, Belgium More Info
Christy Van Der Perren
Contact
Vincent Verschaeve, MD
Principal Investigator
Centre Hospitalier de Ardenne - Libramont - Clinique du Sein
Libramont Luxembourg, 6800, Belgium More Info
Louis Celine
Contact
Frederic Forget, MD
Principal Investigator
Centre Hospitalier Universitaire (CHU) - Universite Catholique de Louvain (UCL) - Namur - Site Godinne (Cliniques Universitaires UCL de Mont-Godinne)
Godinne Namur, 5300, Belgium More Info
Frederic Bellemans
Contact
Lionel D'Hondt, MD
Principal Investigator
Algemeen Ziekenhuis Maria Middelares
Gent , 9000, Belgium More Info
Thomas Hollevoet
Contact
Christof Vulsteke, MD
Principal Investigator
Institut Bergonié
Bordeaux Gironde, 33076, France More Info
Claire Laillault
Contact
Roubaud Guilhem, MD
Principal Investigator
Institut régional du Cancer de Montpellier - ICM Val d'Aurelle
Montpellier Herault, 34298, France More Info
Sarah Nauleau
Contact
Diego Tosi, MD
Principal Investigator
Hôpital d'Instruction des Armées Bégin
Saint-Mandé Ile De France, 94160, France More Info
Salima Bouktit
Contact
Carole Helissey, MD
Principal Investigator
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire Ille Et Vilaine, 35760, France More Info
Julie Hamery-Gruel
Contact
Xavier Artignan, MD
Principal Investigator
Radiation Oncology Unit, Azienda Ospedaliera Universitaria Careggi, University of Florence
Florence , 50134, Italy More Info
Lucia Paolini
Contact
Lorenzo Livi, MD
Principal Investigator
Chonnam National University Hospital
Gwangju , 61469, Korea, Republic of More Info
Areum Kim
Contact
Taek Won Kang, MD
Principal Investigator
Seoul National University Hopital
Seoul , 03080, Korea, Republic of More Info
Jeonghwa Lee
Contact
Cheol Kwak, MD
Principal Investigator
Yonsei University Health System, Severance Hospital
Seoul , 03722, Korea, Republic of More Info
Areum Kwon
Contact
Sangjoon Shin, MD
Principal Investigator
Hospital Universitari Parc Taulí
Sabadell Barcelona, 08208, Spain More Info
Marta Garante
Contact
Enrique Gallardo, MD
Principal Investigator
Hospital Clinic de Barcelona
Barcelona , 08036, Spain More Info
Airan Alonso
Contact
Dra Begona Mellado, MD
Principal Investigator
Hospital de la Santa Creu I Sant Pau
Barcelona , 08036, Spain More Info
Ona Ramirez
Contact
Jose Pablo Maroto Rey, MD
Principal Investigator
Hospital Universitario Lucus Augusti
Lugo , 27002, Spain More Info
Raquel Romero Van Der Schoot
Contact
Sergio Vazquez Estevez, MD
Principal Investigator
The Royal Marsden NHS Trust
Sutton Surrey, SM2 5, United Kingdom More Info
Johann De Bono
Contact
Johann De Bono, MD
Principal Investigator
Oxford University Hospitals NHS- Churchill Hospital
Oxford , OX3 7, United Kingdom More Info
Mark Tuthill
Contact
Mark Tuthill, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05551117

Recruitment Status:

Recruiting

Sponsor:


MacroGenics

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